MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND DYNAGEN; IMPLANTABLE CHF GENERATOR

Model Number G150

Device Problems Over-Sensing (1438); Under-Sensing (1661)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that this patient presented to the emergency room due to hypertension, dizziness and worsening heart failure.Upon review, it was found the patient went into atrial fibrillation.The device also was found to have exhibited undersensing and oversensing which was observed on the left ventricular (lv) channel.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.

• Brand Name: DYNAGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6475307
• MDR Text Key: 72203053
• Report Number: 2124215-2017-01236
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: (01)00802526534614(17)20170623
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2017
• Device Model Number: G150
• Other Device ID Number: DYNAGEN CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0293; 4136; 4542; G150
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR